FDA.report

Maxima™ ACP System

Primary DI
08800015957649
Brand
Maxima™ ACP System
Company
Innosys Co., Ltd.
Model
SC7230
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015957649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015957649088000159576498800015957649

GMDN Terms

TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08800037597915UniSpace® Stand-Alone C CageAUS10112024-12-07
08800037597922UniSpace® Stand-Alone C CageAUS10122024-12-07
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08800247357095GENERAL HANDLEGH11302024-12-07
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08800247356937INNOVERSE SPINAL SYSTEMNP09122024-12-02
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08800247356951INNOVERSE SPINAL SYSTEMNP09142024-12-02
08800247356968INNOVERSE SPINAL SYSTEMNP09152024-12-02
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08800247356982INNOVERSE SPINAL SYSTEMNP09172024-12-02
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08800247357019INNOVERSE SPINAL SYSTEMNP09232024-12-02
08800247357026INNOVERSE SPINAL SYSTEMNP09242024-12-02
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